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This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).
Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.
Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional cast | Active Comparator | conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created |
|
| indirect digital impression and 3D printed cast | Experimental | the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration |
|
| direct digital impression | Experimental | the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indirect digital impression and 3D printed cast | Procedure | the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration |
| Measure | Description | Time Frame |
|---|---|---|
| 3D RMS - root mean square difference | The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP | at impression taking, 0,2,10,20 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Linear vertical soft tissue change | Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels | at impression taking, 0,2,10,20 mins |
| Linear horizontal soft tissue change |
| Measure | Description | Time Frame |
|---|---|---|
| Pink esthetic score/PES | pink esthetic score of the definitive restoration | at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up |
| White esthetic score/WES |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krisztina Mikulás, PhD | Contact | +3614591500 | 59115 | mikulas.krisztina1@semmelweis.hu |
| Xinyi Qian | Contact | +3614591500 | 59313 | qian.xinyi@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Krisztina Mikulás, PhD | Department of Prosthodontics, Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University, Department of Prosthodontics | Recruiting | Budapest | Pest County | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30885583 | Background | Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15. | |
| 35290685 | Background | Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26. |
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|
| direct digital impression | Procedure | the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration |
|
| conventional impresion and cast | Procedure | conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created |
|
Horizontal thickness change of the buccal and palatal gingiva at three levels at each third of the distance between the implant platform and the marginal gingiva.
| at impression taking, 0,2,10,20 mins |
| 2D RMS - root mean square difference | The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections. | at impression taking, 0,2,10,20 mins |
| Patient reported outome measures - evaluation of the impression method | Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire | at the end of each session of the digital and conventional impression taking |
white esthetic score of the definitive restoration
| at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up |
| functional implant prosthodontic score/FIPS | functional implant prosthodontic score of the definitive restoration | at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up |
| 30357992 | Background | Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3. |
| ID | Term |
|---|---|
| C119975 | POLR1G protein, human |
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